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Se-Tan PLUS (Seton Pharmaceuticals)

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CAPSULE, GELATIN COATED 90 CAPSULE, GELATIN COATED in 1 BOTTLE (13925-118-90) Label Information

Complete Se-Tan PLUS Information

  • BOXED WARNING(What is this?)

    WARNING: Accidental overdose of iron-containing products is the leading cause of fatal poisoning in children under six. Keep this and all drugs out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.


  • SPL UNCLASSIFIED SECTION

    Ferrous Fumarate / Polysaccharide Iron Complex / Multivitamin Mineral Capsules

    Rx Only


  • DESCRIPTION

    DESCRIPTION: Each capsule contains:

    Ferrous Fumarate (anhydrous) 162 mg
    Polysaccharide Iron Complex
    (Equivalent to about 106 mg
    of elemental iron)
    115.2 mg
    Vitamin C (Sodium Ascorbate) 200 mg
    Vitamin B1
    (Thiamine Mononitrate)
    10 mg
    Vitamin B2 (Riboflavin) 6 mg
    Vitamin B6 (Pyridoxine HCI) 5 mg
    Vitamin B12
    (Cyanocobalamin Concentrate)
    15 mcg
    Folic Acid 1 mg
    Niacinamide 30 mg
    Pantothenic Acid
    (as Calcium Pantothenate)
    10 mg
    Zinc (as Zinc Sulfate) 18.2 mg
    Manganese
    (as Manganese Sulfate)
    1.3 mg
    Copper (as Copper Sulfate) 0.8 mg

  • Inactive Ingredients:

    FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, Gelatine, Magnesium Stearate, Microcrystalline Cellulose, Silica, Titanium Dioxide.


  • INDICATIONS:

    Se-Tan PLUS is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age. Also for treatment of condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.


  • CONTRAINDICATIONS:

    Se-Tan PLUS is contraindicated in patients with a known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.


  • WARNINGS

    WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.


  • PRECAUTIONS:


  • GENERAL PRECAUTIONS

    General: Folic acid in doses above 0.1 mg - 0.4 mg daily may obscure pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive.


  • PEDIATRIC USE

    Pediatric Use: Safety and effectiveness of this product have not been established in pediatric patients.


  • GERIATRIC USE

    Geriatric Use: No clinical studies have been performed in patients age 65 and over to determine whether older persons respond differently from younger persons. Dosage should always begin at the low end of the dosage scale and should consider that elderly persons may have decreased hepatic, renal, or cardiac function and or concomitant diseases.


  • Adverse Reactions:

    Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.

    Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Se-Tan PLUS after meals may control occasional G.I. disturbances. Se-Tan PLUS is best absorbed when taken at bedtime.


  • OVERDOSE:

    Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300-mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. Se-Tan PLUS should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all other drugs out of the reach of children.

    Treatment: For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.


  • DOSAGE AND ADMINISTRATION:

    Adults (persons over 12 years of age), one (1) capsule daily, orally, between meals, or as prescribed by a physician. Do not exceed recommended dosage. Do not administer to children under the age of 12.


  • HOW SUPPLIED:

    Se-Tan PLUS are white capsules imprinted in black "T503". Child resistant bottles of 90 capsules. NDC 13925-118-90.

    Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.


  • Storage:

    Store at controlled room temperature 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Keep in a cool, dry place.


  • SPL UNCLASSIFIED SECTION

    KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

    Rx Only

    RESERVED FOR PROFESSIONAL RECOMMENDATION.

    Manufactured for:
    Seton Pharmaceuticals
    Manasquan, NJ 08736
    1-800-510-3401

    MADE IN CANADA

    Rev. 09/10

    SETON PHARMACEUTICALS


  • PRINCIPAL DISPLAY PANEL

    NDC 13925-118-90

    Se-Tan-PLUS

    Ferrous Fumarate / Polysaccharide Iron Complex /
    Multivitamin Mineral Capsules

    90 Capsules

    Rx Only

    SETON PHARMACEUTICALS

    Container Label

  • INGREDIENTS AND APPEARANCE
    SE-TAN PLUS 
    multivitamin/mineral capsule, gelatin coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13925-118
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FERROUS FUMARATE (UNII: R5L488RY0Q) (IRON - UNII:E1UOL152H7) FERROUS FUMARATE 162 mg
    IRON DEXTRAN (UNII: 95HR524N2M) (IRON - UNII:E1UOL152H7) IRON DEXTRAN 115.2 mg
    SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 200 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE - UNII:X66NSO3N35) THIAMINE 10 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 6 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 5 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 15 ug
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 30 ug
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID 10 mg
    ZINC SULFATE (UNII: 89DS0H96TB) (ZINC - UNII:J41CSQ7QDS) ZINC 18.2 mg
    MANGANESE SULFATE (UNII: W00LYS4T26) (MANGANESE - UNII:42Z2K6ZL8P) MANGANESE 1.3 mg
    CUPRIC SULFATE (UNII: LRX7AJ16DT) (COPPER - UNII:789U1901C5) COPPER 0.8 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 23mm
    Flavor Imprint Code T503
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:13925-118-90 90 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/01/2009
    Labeler - Seton Pharmaceuticals (828898002)
    Establishment
    Name Address ID/FEI Business Operations
    VIVA 253288898 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Rainbow Gold 800695152 REPACK